Revised: January 2015
AN. 00171/2014
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Adrenacaine Solution for Injection for Cattle
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Substance:
Procaine Hydrochloride
Adrenaline (Epinephrine) (as Adrenaline Tartrate)
50mg/ml
0.02mg/ml
Excipients:
Chlorocresol (as preservative)
Sodium Metabisulphite E223 (as antioxidant)
1.0mg/ml
1.0mg/ml
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
A clear colourless solution.
4.
CLINICAL PARTICULARS
4.1
Target species
Cattle
4.2
Indications for use, specifying the target species
The product is indicated for use in minor surgical procedures particularly
dehorning and disbudding in cattle
4.3
Contraindications
Do not administer by intravenous, intra-articular or epidural injection.
Do not use in cases of hypersensitivity to the active substances or to any of
the excipients.
4.4
Special Warnings for each target species
None known.
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4.5
Special precautions for use
i
Special precautions for use in animals
Care should be taken not to inject the product intravascularly.
ii
Special precautions to be taken by the person administering the
veterinary medicinal product to animals
Care should be taken to avoid accidental self-injection.
In case of accidental self-injection, seek medical advice immediately and
show the package leaflet or label to the physician. Immediately wash off any
splashes to the eyes or skin with copious amounts of water.
Seek medical attention if irritation occurs.
Wash hands after use.
4.6
Adverse reactions (frequency and seriousness)
None known.
4.7
Use during pregnancy, lactation or lay
The product can be administered at any stage of pregnancy or lactation.
4.8
Interaction with other medicinal products and other forms of interaction
Procaine may inhibit the action of sulfonamides and their concurrent
administration should be avoided.
4.9
Amounts to be administered and administration route
The product should be administered by subcutaneous injection as follows:
Cattle: 2-5 ml
Avoid excessive broaching.
Do not exceed the recommended dose.
4.10
Overdose (symptoms, emergency procedures, antidotes), if necessary
The product is well tolerated at doses up to 3 times the recommended dose
for cattle.
Local anaesthetics used in excess can cause systemic toxicity characterised
by CNS effects. If systemic toxicity occurs, as a result of inadvertent intravascular injection, the administration of oxygen to treat cardio-respiratory
depression and diazepam to control convulsions should be considered.
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4.11
Withdrawal period
Meat and offal:
Milk:
5.
Zero days
Zero hours
PHARMACOLOGICAL PROPERTIES
Pharmacotherapeutic group: Anaesthetic
ATC Vet Code: QN01BA52
5.1
Pharmacodynamic properties
Procaine (p-aminobenzoyl-diethyl aminoethanol) is an amino ester. Procaine,
a local anaesthetic shares with other chemical families the ability to act as a
membrane stabiliser, by interfering with the ability of excitable cells to
generate or transmit impulses. Procaine blocks conduction by decreasing or
preventing the large transient increase in the permeability of excitable
membranes to Na+ that is produced by a slight depolarisation. The action of
local anaesthetics is due to their direct interaction with voltage sensitive Na+
channels.
Adrenaline is composed of two major constituents, the aromatic portion of the
molecule consists of 1,2-dihydroxybenzene (catechol), the aliphatic portion
consists of ethanol-amine.
The duration of the action of local anaesthetics is proportional to the time
which they are in actual contact with nervous tissue.
Consequently
procedures which localise the drug at the nerve greatly prolong the period of
anaesthesia. It has been demonstrated that the addition of epinephrine to
local anaesthetic solutions greatly prolongs and intensifies their action.
Epinephrine performs a dual service. By decreasing the rate of absorption it
not only localises the anaesthetic agent at the desired site but also allows the
rate at which the anaesthetic is destroyed in the body to keep pace with the
rate at which it enters the circulation. This greatly reduces systemic toxicity.
5.2
Pharmacokinetic particulars
Procaine Hydrochloride is a local anaesthetic. The in-vitro half-life of in
plasma is less than 1 minute. It is only slightly bound to plasma protein
(5.8%) and has a duration of anaesthetic effect of about 50 minutes in man.
Adrenaline is added to local anaesthetics such as Procaine Hydrochloride to
slow diffusion and limit absorption as it constricts arterioles and capillaries, so
prolonging the duration of the effect and lessening the danger of toxicity.
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6.
PHARMACEUTICAL PARTICULARS
6.1
List of excipients
Sodium Metabisulphite (E223)
Chlorocresol
Sodium Chloride
Sodium Hydroxide (pH adjustment)
Hydrochloric Acid (pH adjustment)
Water for Injections
6.2
Incompatibilities
In the absence of compatibility studies, this veterinary medicinal product must
not be mixed with other veterinary medicinal products.
6.3
Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale: 2 years
Shelf-life after first opening the immediate packaging: 28 days
6.4
Special precautions for storage
Do not store above 25C.
Protect from light.
6.5
Nature and composition of immediate packaging
The product will be supplied in 100 ml amber type I glass vials with
bromobutyl bungs and aluminium caps.
6.6
Special precautions for the disposal of unused veterinary medicinal
product or waste materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from
such veterinary medicinal products should be disposed of in accordance with
local requirements.
7.
MARKETING AUTHORISATION HOLDER
Norbrook Laboratories Limited
Station Works
Camlough Road
Newry
Co. Down
BT35 6JP
Northern Ireland
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8.
MARKETING AUTHORISATION NUMBER
Vm 02000/4243 (UK)
VPA 10999/123/001 (IE)
9.
DATE OF FIRST AUTHORISATION
07 July 2004
10.
DATE OF REVISION OF THE TEXT
January 2015
Approved:
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23/01/2015